Catalog Number 261221 |
Device Problem
Fail-Safe Did Not Operate (4046)
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Patient Problem
Brain Injury (2219)
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Event Type
Injury
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Manufacturer Narrative
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An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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A facility reported a perforator (id 261221) failed to disengage causing damage to the dura with a small amount of cortical bleeding.As it was subdural, there was no significant injury and surgeon was able to control the bleeding.The event led to 20-30 minutes surgical delay.
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Manufacturer Narrative
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The perforator was returned for evaluation: dhr - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - the perforator unit was inspected using the unaided eye.An unused unit from the same lot was returned since the customer could not provide the original unit.The unit was found to work as intended, and met all acceptance criteria.The complaint could not be verified through failure analysis.Root cause is undetermined and was unable to be confirmed in the complaint evaluation.
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Search Alerts/Recalls
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